Bolar Pharmaceutical Co.'s former director of regulatory affairs has pleaded guilty to federal criminal charges for lying to the U.S. Food and Drug Administration and falsifying company records to obstruct an FDA inspection.
Susan M. Long, 44, of Long Island, N.Y., entered guilty pleas Tuesday to false statement and obstruction charges before Judge John R. Hargrove in U.S. District Court in Baltimore. The judge set sentencing for June 14.
Long is the 17th defendant to plead guilty to criminal charges in a 2 1/2 -year probe centered in the U.S. attorney's office here, and the third Bolar official convicted of charges tied to the company's manufacture of Triamterene Hydrochlorothiazide, a generic hypertension drug.
Bolar sold $140 million worth of the popular Dyazide substitute before the FDA pulled it off the market early last year in the wake of evidence of product-switching and other corruption in the company.
Justice Department prosecutor Lawrence G. McDade said in court that Long produced false records for FDA inspections at least twice in 1989, once on the ingredient Triamterene and once on several other drugs to cover up the Triamterene record falsifications.